Atrial Fibrillation, Stroke
Conditions
Keywords
Transient Atrial Fibrillation, Perioperative Atrial Fibrillation, Non-vitamin K Oral Anticoagulation, Noncardiac Surgery, PROBE Design, Medical Illness, Stress
Brief summary
Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.
Detailed description
ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient atrial fibrillation and additional stroke factors occurring transiently with stress. The primary objective is to assess the effects of NOACs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.
Interventions
DRUGNon-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.
Sponsors
Population Health Research Institute
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective, randomized, open-label clinical trial with blinded outcome assessment
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. have ≥1 episode of clinically important AFOTS during any of the following conditions: 1. noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery; 2. noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or 3. acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; 2. sinus rhythm at the time of randomization; 3. any of the following high-risk criteria: 1. age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level; 2. age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR 3. age ≥75 years.; 4. provide written informed consent
Exclusion criteria
1. any cardiac diagnosis as the primary reason for hospital admission; 2. history of documented chronic AF prior to noncardiac surgery; 3. need for long-term systemic anticoagulation; 4. ongoing need for long-term dual antiplatelet treatment; 5. contraindication to oral anticoagulation; 6. severe renal insufficiency (CrCl \<20 ml/min); 7. severe liver cirrhosis (i.e., Child-Pugh Class C) 8. acute stroke in the past 14 days; 9. underwent cardiac surgery in the past 35 days; 10. history of nontraumatic intracranial, intraocular, or spinal bleeding; 11. hemorrhagic disorder or bleeding diathesis; 12. expected to be non-compliant with follow-up and/or study medications; 13. known life expectancy less than 1 year due to concomitant disease; 14. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR 15. previously enrolled in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Non-hemorrhagic stroke or systemic embolism | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) |
| Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Myocardial infarction | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) |
| Incidence of peripheral arterial thrombosis | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) |
| Incidence of amputation | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) |
| Incidence of symptomatic venous thromboembolism | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) |
| Incidence of all-cause stroke | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) |
| Incidence of all-cause mortality | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) |
| Incidence of vascular mortality | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) |
| Incidence of non-fatal, non-hemorrhagic stroke | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization for vascular causes | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) | Tertiary Objective |
| Hospitalization for all causes | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) | Tertiary Objective |
| Incidence of major bleeding | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) | Safety objective, measured according to the ISTH criteria |
| Incidence of hemorrhagic stroke | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) | Safety objective |
| Incidence of composite of life-threatening, major, and critical organ bleeding | For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) | Safety objective, measured as previously done in the MANAGE trial |
Countries
Argentina, Australia, Brazil, Canada, Denmark, Finland, Germany, India, Italy, Nepal, Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Primary ContactCassie McDonald
Outcome results
None listed